Plain English Summary
Not provided at time of registration
Trial website
http://www.cardiff.ac.uk/medic/subsites/buildingblocks/index.html
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.4
Study information
Scientific title
Evaluating the family nurse partnership programme in England: a randomised controlled trial
Acronym
Building Blocks
Study hypothesis
The purpose of this study is to see if providing young first time mothers with extra support before and after the birth is helpful for both mother and child. We are specifically interested in whether the programme makes a difference to the mother and baby's health and behaviour:
1. During pregnancy and at birth
2. In the first two years after birth
On 13/01/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 31/01/2013 to 19/09/2014.
2. The target number of participants was changed from 2400 to 1600.
Ethics approval
Research Ethics Committee (REC) for Wales gave approval on the 17th February 2009 (ref: 09/MRE09/08)
Study design
Individually randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
First time pregnancy
Intervention
This trial will assess the effectiveness of the FNP in England compared with existing universal services, in achieving its stated objectives (namely, to improve pregnancy outcomes, child health and development and parents' economic self-sufficiency).
The trial will start after consent and recruitment into the trial. Participants will be recruited into the trial as soon as the pregnancy is confirmed but before 24 weeks gestation. Participants will be randomised to either entry into the FNP programme arm or to the control arm (universal services), and will be followed up until 2 years after the birth of the child. The whole trial will last 52 months. Interviews (either face-to-face or by telephone) for both arms of the trial will be at baseline, 34 - 36 weeks gestation and 6, 12, 18 and 24 months after birth.
If participants are selected to join the group that receives the FNP programme, they will receive visits from a specially trained 'Family Nurse'. The Family Nurse would normally go to the participants' home, but can see you somewhere else if they prefer. The Family Nurse will visit the participant every week for the first month after they join the study, and then every other week until the baby is born. The Family Nurse will then visit the participant weekly until the baby is six weeks old and then once every two weeks until the child is 20 months old. The last four visits are monthly until the child is 2 years old.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Changes in prenatal tobacco use (maternal measure), measured at baseline and 34 - 36 weeks gestation interviews
2. Birth weight (child measure), measured at birth (collected afterwards)
3. Emergency attendances/admissions within two years of birth, measured at all timepoints
4. Proportion of women with a second pregnancy within two years of first birth, measured at all timepoints
Secondary outcome measures
1. Intention to breastfeed
2. Prenatal attachment
3. Injuries and ingestions
4. Breast feeding (initiation and duration)
5. Language development
6. Education
7. Employment
8. Income/benefits
9. Home (tenure)
10. Health status
11. Self-efficacy
12. Social support
13. Paternal involvement
Timepoints not finalised as of 24/03/2009.
Overall trial start date
06/04/2009
Overall trial end date
19/09/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women aged 19 years or under (at recruitment/consent)
2. Lives within the catchment area covered by the local family nurse partnership (FNP) team
3. First pregnancy confirmed by health services (including those expecting multiple birth) unless previous pregnancy ended in miscarriage, stillbirth or termination
4. Recruited no later than 24 weeks
5. Gillick competent to provide adequate informed consent to research participation including competence in English at conversational level or higher
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1600
Participant exclusion criteria
1. Women who at study entry, plan to have their child adopted
2. Women who at study entry, plan to leave the FNP area during the time of the trial either for an extended period of time (3 months or longer) or permanently
3. Women who would require a third person (translator, sign interpreter) to receive the FNP programme
Recruitment start date
25/06/2009
Recruitment end date
28/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South East Wales Trials Unit (SEWTU)
Institute of Primary Care and Public Health
Cardiff University
7th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Policy Research Programme
Research and Development Directorate
NIHR CCF PO Box 407
Teddington
Middlesex
Teddington
TW11 0XX
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) (ref: 006/0060) - Policy Research Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary